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Chemotherapy

Chemotherapy + Immunotherapy for Lung Cancer

Phase 2

Recruiting

Led By Missak Haigentz, MD

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with any evidence of Small Cell Carcinoma will be excluded from study participation

Patients must have histologically or cytologically confirmed stage IV NSCLC (includes M1a, M1b, and M1c stage disease, AJCC 8th edition)

Must not have

Patients with known EGFR mutations (except exon 20 insertion), BRAF mutations (V600), MET Exon14 skipping or ALK or ROS1 translocations that can be treated with oral tyrosine kinase inhibitors are excluded

History of active malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to treat lung or head and neck cancer by combining chemotherapy and immunotherapy.

Who is the study for?

This trial is for adults with advanced lung or head and neck cancers. Participants must have a certain level of physical fitness (ECOG 0-2) and measurable disease. They should not be pregnant, breastfeeding, or have severe infections, organ transplants, autoimmune diseases requiring treatment in the past 2 years, known specific cancer mutations, or pre-existing severe lung conditions.

What is being tested?

The study tests alternating cycles of chemoimmunotherapy (chemo drugs like Paclitaxel combined with Pembrolizumab) and immunotherapy alone as initial treatments. It aims to see if changing treatment types can better manage advanced cancers.

What are the potential side effects?

Possible side effects include allergic reactions to medication components, immune system complications leading to inflammation in various organs, fatigue from chemotherapy drugs like Carboplatin and Pemetrexed, digestive issues such as diarrhea from 5Fluorouracil, blood disorders due to bone marrow suppression by chemotherapeutic agents.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is not small cell carcinoma.

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My lung cancer is at stage IV.

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I can take care of myself and am up and about more than half of my waking hours.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer does not have treatable mutations like EGFR (except exon 20), BRAF (V600), MET Exon14, ALK, or ROS1.

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I have a history of cancer.

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I have had a condition where my lymphocytes grow abnormally.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Confidence Interval (CI) estimate of patients completing induction chemotherapy cycles

Secondary study objectives

Overall response rates

Safety as assessed by number of participants experiencing adverse events

Other study objectives

Health Related Quality of Life (HRQoL) assessment (Head and Neck Cancer)

Malignant Neoplasms

Tumor immune microenvironment (TME) evaluation of biopsy tissues, via tumor markers

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Localised oedema

Ear pain

Urinary tract infection

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Pneumonia aspiration

Sepsis

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Clostridium difficile colitis

Cardiac arrest

Systemic infection

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Placebo + CRT Followed by Placebo

Pembrolizumab + CRT Followed by Pembrolizumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Squamous Lung CancerExperimental Treatment3 Interventions

A Cycles consist of either: * Paclitaxel Based: Carboplatin/Paclitaxel/Pembrolizumab OR * nab-Paclitaxel Based: Carboplatin/nab Paclitaxel/Pembrolizumab These A Cycles will be given for up to four cycles (standard) B Cycles consist of Pembrolizumab alone

Group II: Non-Squamous Lung CancerExperimental Treatment3 Interventions

* A Cycles consist of Carboplatin/Pemetrexed/Pembrolizumab (up to four cycles standard) * B Cycles consist of Pembrolizumab alone Maintenance Cycles (Cycle 5 and beyond): Pemetrexed in combination with Pembrolizumab; Alternatively, Pembrolizumab alone, for up to 2 years since enrollment (standard)

Group III: Head and Neck Squamous Cell CarcinomaExperimental Treatment3 Interventions

* A Cycles consist of Carboplatin/5-Fluorouracil/Pembrolizumab (up to six cycles standard) * B Cycles consist of Pembrolizumab alone Maintenance Cycles (Cycle 7 and beyond): Pembrolizumab alone, for up to two years since enrollment (standard)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5450

Pemetrexed

2014

Completed Phase 3

~5550